Asbestos Exposure, Pleural Mesothelioma and Osteopontin Levels

Abstract

The present invention provides diagnostic and disease progression or recurrence prediction methods based on osteopontin levels in a biological sample.

1 . A method of diagnostically evaluating a human subject to predict pleural mesothelioma progression or recurrence, comprising: (a) obtaining a biological sample from said subject; (b) assaying said sample for the concentration of osteopontin present; (c) comparing the results obtained from the assay of step (b) with results obtained from the assay of one or more control samples; and (d) concluding that said subject is at increased risk of pleural mesothelioma progression or recurrence if the concentration of osteopontin in said subject sample is higher than the concentration in said control sample or samples. 
     
     
         2 . The method of  claim 1 , wherein the concentration of osteopontin present in said samples is determined by an immunoassay. 
     
     
         3 . The method of  claim 1 , wherein the concentration of osteopontin in said sample is determined using an ELISA. 
     
     
         4 . The method of  claim 1 , wherein said biological sample is plasma. 
     
     
         5 . The method of  claim 1 , wherein said one or more control samples are obtained from asbestos-exposed subjects. 
     
     
         6 . The method of  claim 1 , wherein the results from said subject sample is compared to the results obtained from a group of control samples taken from the general population. 
     
     
         7 . The method of  claim 1 , wherein it is concluded that a subject is at increased risk of mesothelioma progression or recurrence if the osteopontin concentration in said subject sample is higher than the amount in said control sample or samples by a predetermined value. 
     
     
         8 . The method of  claim 1 , further comprising performing at least one additional assay for a diagnostic marker of cancer. 
     
     
         9 . The method of  claim 8 , wherein said cancer is non-mesothelioma asbestos-related lung cancer. 
     
     
         10 . A method of predicting mesothelioma progression or recurrence in a human subject following diagnosis of mesothelioma, comprising: (a) obtaining at least a first and a second biological sample from said subject at different time points during a treatment;
 (b) assaying said samples for the concentration of osteopontin present; (c) comparing the results obtained from the assay of step (b) with results obtained from the assay of a pretreatment sample from said patient; and (d) predicting an outcome related to mesothelioma progression or recurrence if the concentration of osteopontin in said pretreatment sample is higher than the concentration in said first and/or second sample.   
     
     
         11 . The method of  claim 10 , wherein the concentration of osteopontin present in said samples is determined by an immunoassay. 
     
     
         12 . The method of  claim 10 , wherein the concentration of osteopontin in said sample is determined using an ELISA. 
     
     
         13 . The method of  claim 10 , wherein said biological sample is plasma. 
     
     
         14 . The method of  claim 1 , wherein said one or more control samples are obtained from asbestos-exposed subjects. 
     
     
         15 . The method of  claim 10 , wherein the results from said subject sample is compared to the results obtained from a group of control samples taken from the general population. 
     
     
         16 . The method of  claim 10 , wherein it is concluded that a subject is at increased risk of mesothelioma progression or recurrence if the osteopontin concentration in said subject sample is higher than the amount in said control sample or samples by a predetermined value. 
     
     
         17 . The method of  claim 10 , further comprising performing at least one additional assay for a diagnostic marker of cancer. 
     
     
         18 . The method of  claim 17 , wherein said cancer is non-mesothelioma asbestos-related lung cancer. 
     
     
         19 . A method of assessing the likelihood that a human patient will develop recurrent mesothelioma following tumor resection, the method comprising assessing the amount of osteopontin in a sample obtained from the patient and comparing that amount with a reference value derived from one or more reference humans of known mesothelioma outcome, whereby the comparison indicates the likelihood that the patient will develop recurrent mesothelioma following tumor resection.